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Metastatic Castration Resistant Prostate CancerPhase 1NCT05673109

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing AC176 in people with Metastatic Castration Resistant Prostate Cancer, run by Accutar Biotechnology Inc at 5 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This clinical trial is evaluating a drug called AC176 in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least one prior systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
AC176
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
5 sitesChina
Study dates
22 Feb 2023to 8 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients who are ≥ 18 years old when signing the ICF.
  • Patients with histologically, pathologically or cytologically confirmed mCRPC, except for any suspected neuroendocrine or small cell carcinoma. Patients with disease progression confirmed according to the Prostate Cancer Working Group 3 (PCWG3) Criteria, following standard of care, or for whom standard of care is inappropriate (they cannot tolerate or are unwilling to receive the standard of care), or for whom no therapy with proven efficacy is available.
  • Patients with disease progression meeting at least one of the following PCWG3 criteria:Positive bone scan (≥ 2 new lesions) or soft tissue metastases on CT/MRI ; or If PSA progression is the sole criterion for progression, its starting value of ≥ 1.0 ng/mL has been elevated twice at least 1 week apart.
  • Patients must have disease progression (in any stage of prostate cancer) after at least 1 of previously approved systemic therapies, at least 1 of which is Abiraterone, Enzalutamide, Apalutamide or Darolutamide.
  • The performance status score of the Eastern Cooperative Oncology Organization (ECOG) is 0-1.
  • Male patients with female partners of childbearing potential are required to use two forms of acceptable contraceptive measures.
  • Life expectancy ≥ 3 months after initiation of treatment, in the investigator's opinion.

Who cannot join

  • Patients meeting any of the following criteria will be excluded from the study:
  • Patients who have received any of the following treatments:
  • More than 2 lines of chemotherapy at any stage of prostate cancer treatment; Any systemic anti-cancer chemotherapy, biological agent in the previous treatment regimen or clinical study within 4 weeks prior to the first dose of the investigational drug; any systemic small molecule drug within 2 weeks prior to the first dose or 5 half-lives (whichever is longer, but no more than 4 weeks), except for the use of ADT for medical castration purposes; Any investigational drugs in previous clinical studies within 4 weeks before the first dose of the study treatment; Radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of the investigational drug; or radiotherapy for remission within 2 weeks prior to the first dose. Palliative radiotherapy for relieving the pain caused by bone metastases.
  • Patients who have any > Grade 1 unresolved toxicity from prior therapy at the time of initiation of study treatment, except for alopecia and ≤ Grade 2 peripheral neuropathy (as assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]).
  • Patients who have received any major surgery(ies) (with the exception of the placement of vascular access) within 4 weeks prior to the first dose of the investigational drug.
  • Patients with known brain metastasis.
Show all 11Show fewer
  • Male patients who plan to have children during the study or within 90 days after the last dose of investigational drug.
  • Patients who have any condition that impairs their ability to swallow a tablet whole, or have active gastrointestinal disease or other conditions that may significantly interfere with the absorption, distribution, metabolism or excretion of AC176
  • Patients whose cardiac functions currently meet or met the following criteria in the past 6 months:
  • Mean corrected QT interval (QTc) in resting ECG is > 470 ms; Resting ECG shows clinically significant abnormalities ; Presence of any potential risk factors that may prolong QTc interval or increase the risk of arrhythmia, Left ventricular ejection fraction (LVEF) is < 50% or < the study site's LLN;
  • Patients presenting evidence(s) which is(are), in the opinion of the investigator, indicative of any serious or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses or active infection, with no need to screen for chronic diseases.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Site 2001

    Beijing

  • Site 2003

    Guangzhou

  • Site 2004

    Hunan

  • Site 2005

    Nanchang

  • Site 2002

    Shanghai

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of AC176 in Chinese Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

This clinical trial is evaluating a drug called AC176 in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least one prior systemic therapy.

The main goals of this study are to:

Evaluate the safety and tolerability of AC176, evaluate pharmacokinetics and preliminary antitumor activity of AC176

Read the detailed description

AC176-002 is a Phase I, open-label, multi-center dose-escalation study of AC176 given orally as a single agent. The AC176 is an investigational medicinal product that is a potent orally bioavailable Androgen Receptor (AR) degrader studied for the treatment of patients with metastatic castration resistant prostate cancer.

Being tested
AC176
Keywords
Metastatic Castration Resistant Prostate Cancer,, mCRPC;, Androgen Receptor,, Androgen Receptor Degrader,, AC176,, Phase 1
Medical subject headings
Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC176Drug

    AC176 will be given orally (PO) on a 28-day cycle.

Study groups in NCT05673109
Study groupRoleWhat they receive
AC176ExperimentalSingle agent dose escalation of AC176. AC176 will be given orally (PO) on a 28-day cycle.
Receives: Drug: AC176

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)/Serious adverse events (SAEs)

    Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC176

    Measured: Through study completion, approximately 24 months

  2. Clinically significant abnormalities in vital signs

    Vital signs abnormalities as characterized by type, frequency, severity and timing;

    Measured: Through study completion, approximately 24 months

  3. Clinically significant abnormalities in laboratory tests

    Laboratory abnormalities as characterized by type, frequency, severity and timing;

    Measured: Through study completion, approximately 24 months

  4. Clinically significant abnormalities in electrocardiogram (ECG)

    Electrocardiogram (ECG) abnormalities such as QTcF, PR, RR and QRS intervals

    Measured: Through study completion, approximately 24 months

  5. Clinically significant abnormalities in heart rate

    Measured: Through study completion, approximately 24 months

Secondary outcomes (9)

  1. Prostate-specific antigen (PSA) response rates based on Prostate Cancer Working Group 3 (PCWG3) criteria.

    PSA response rate per PCWG3

    Measured: Throughout the study, approximately 24 months

  2. Objective Response Rate(ORR)

    Measured: Throughout the study, approximately 24 months

  3. Radiographic progression-free survival (rPFS)

    Measured: Throughout the study, approximately 24 months

  4. Time to progression (TTP)

    Measured: Throughout the study, approximately 24 months

  5. Duration of response (DoR)

    Measured: Throughout the study, approximately 24 months

  6. Progression-free survival (PFS)

    Measured: Throughout the study, approximately 24 months

  7. Pharmacokinetic Analysis

    Area under the concentration-time curve over the dosing interval (AUC(0-tau))

    Measured: 24 weeks

  8. Pharmacokinetic Analysis

    Maximum plasma concentration (Cmax)

    Measured: 24 weeks

  9. Pharmacokinetic Analysis

    Terminal elimination half life (t1/2)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start22 Feb 2023
  3. Primary completion8 Oct 2023
  4. Study completion8 Oct 2023

Why it stopped: Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673109
Sponsor's protocol ID
AC176-002
Status last verified
Jan 2024
First submitted
19 Dec 2022
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AC176 in people with Metastatic Castration Resistant Prostate Cancer, run by Accutar Biotechnology Inc at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs)/Serious adverse events (SAEs) (time frame: Through study completion, approximately 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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